Silent effusion removal

ABSTRACT

A method is disclosed for clearing effusion from an ear. The method may include applying liquid to an ear canal, which is proximal to a perforated tympanic membrane, which is proximal to a middle ear containing effusion, applying an ear device to seal and pressurize the liquid inside the ear canal, the ear device regulating the amount of pressure inside the ear canal, and inducing a Eustachian tube, which is distal to the middle ear, to open, which causes the fluid to displace the effusion into the Eustachian tube.

This application claims the benefit of U.S. Provisional Application No.61/140,805, filed Dec. 24, 2008, the entirety of which is incorporatedby reference herein for all purposes.

FIELD OF THE INVENTION

The invention generally relates to methods and devices for treatment ofthe ear, which may be supplemental to a tympanocentesis procedure.

BACKGROUND OF THE INVENTION

Middle ear infections are common in young children. Suffering may bealleviated by puncturing the tympanic membrane to evacuate the fluid, atreatment known as tympanocentesis. The patient may undergo generalanesthesia prior to a tympanocentesis procedure, but this is notpreferred due to cost and health concerns. As a preferable alternative,the tympanic membrane can be locally anesthetized with an iontophoresisprocedure. Thus, the patient may be treated while awake. Devices andmethods for locally anesthetizing the tympanic membrane are disclosed inco-assigned patent applications U.S. Ser. No. 11/962,063, U.S. Ser. No.11/749,729, and U.S. 61/085,360, the entireties of which areincorporated by reference herein. FIG. 1A shows a view of an outer ear.The outer ear includes a major element known as the Auricle or Pinna100. The outer ear serves as a funnel for directing sounds into theinternal portions of the ear. The major physical features of the earinclude the Lobule 102, Concha 104, Athelix 106, Helix 108, Scapha 110,Triangular fossa 112, Externam acoustic meatus 114, Tragus 116, andAntitragus 118.

FIG. 1B shows a cross-section of the inner and outer portions of theear. The pinna 100 is shown connected to the External auditory meatus118, or ear canal. The ear canal 118 is shown as a relatively straightpassage, but is often a tortuous passageway. The ear canal 118 isconnected to the middle ear 120, which includes the ear drum 122. Themiddle ear 120 in turn is connected to the internal ear 124. When themiddle ear 120 becomes infected, fluid swells inside the ear drum 122.Fluid expansion causes extreme pain to one with a middle ear infection.

Fluid in the middle ear is commonly known as serous otitis media or“effusion”. Effusion is normally drained through the tympanocentesisprocedure. However, effusion may thicken and thus be difficult to removeor drain. Thickening of effusion is common with patients who suffer fromchronic ear infections. Accordingly, a tympanocentesis procedure may notbe effective in patients with lodged or thickened effusion.

Tympanocentesis procedures, which implement iontophoresis, often requireiontophoresis fluid to be evacuated before the tympanic membrane ispunctured. Evacuation of fluid is commonly performed through lowpressure suction via a syringe or suction cannula. Fluid evacuation isoften a painful and uncomfortable process because large amounts of noiseare created by fluid cavitation. Thus, fluid evacuation by suction maycause pain and emotional discomfort which may prevent the completion ofthe tympanocentesis procedure. It should be noted that many patients areyoung, 5 and under, and also have endured many hours or days of apainful ear infection, and thus may be uncooperative and difficult totreat. Fluid may also be removed by swabbing the ear with an absorbentmaterial, however this can be irritating to the patient and ineffectiveas well. Swabbing also requires the patient to vigorously shake theirhead side to side, which many young patients refuse to comply with.

BRIEF SUMMARY OF THE INVENTION

One embodiment of the invention may include a method for clearingeffusion from an ear. The method may include applying liquid to an earcanal, which is proximal to a perforated tympanic membrane, which isproximal to a middle ear containing effusion. The perforated tympanicmembrane may have been intentionally perforated in a priortympanocentesis procedure. The effusion may not have been removed by thenormal tympanocentesis procedure. The method may also include applyingan ear device to seal and pressurize the liquid inside the ear canal,the ear device regulating the amount of pressure inside the ear canal.The method may also include inducing a Eustachian tube, which is distalto the middle ear, to open, which causes the fluid to displace theeffusion into the Eustachian tube.

Another aspect of the invention may include a method for clearingeffusion from an ear, the method including applying an ear device toseal an ear canal, which is proximal to a perforated tympanic membrane,which is proximal to a middle ear containing effusion. The method mayalso include pressurizing the ear canal with air, and inducing aEustachian tube, which is distal to the middle ear, to open, whichcauses the pressurized air to displace the effusion into the Eustachiantube.

Yet another aspect of the invention may include a device forpressurizing an ear canal, the device including a first ear cup whichencloses a first external ear, the first ear cup having a first sealingmember which fluidly seals around the first external ear, the first earcup having a first port which is in fluid communication with the sealedfirst external ear. The device may also include a second ear cup whichencloses a second external ear, the second ear cup having a secondsealing member which fluidly seals around the second external ear, thesecond ear cup having a second port which is in fluid communication withthe sealed second external ear. A headpiece may connect to each ear cup,the headpiece being configured for applying sealing pressure to eachsealing member and retaining each ear cup on each respective externalear.

Yet another aspect of the invention may include a method for clearingliquid from an ear canal, the method including applying a deviceincluding a wicking tip to a liquid solution inside an ear canal to wickthe liquid from the ear canal. The liquid may be left from aiontophoresis procedure. The method may also include applying negativepressure to the device to aid in wicking the liquid, wherein the wickingtip regulates turbulence to reduce noise caused by wicking the liquid.

Yet another aspect of the invention may include a device for clearingliquid from an ear canal, the device including an elongated cannulaincluding a first end and a second end. The device may also include anelongated foam member including a distal end and a proximal end, aportion of the elongated foam member compressed within the cannula, thedistal end uncompressed and exposed past the first end, the proximal enduncompressed and exposed past the second end, wherein the proximal endis larger than the distal end to provide a wicking action to the distalend, and wherein the proximal end will enlarge when fluid is wicked fromthe distal end into the proximal end.

Yet another aspect of the invention may include a device for silentlyremoving liquid from an ear canal, the device including an elongatedmulti-lumen cannula including a distal end and a proximal end, whereineach lumen includes a cross-sectional area which reduces cavitationduring suction. A suction apparatus may be coupled to the proximal endof the multi-lumen cannula.

Yet another aspect of the invention may include a method for removingliquid from an ear canal, the method including receiving a trigger toapply suction to a device in an ear canal filled with liquid, the deviceincluding a lumen for removing the liquid. Suction may be applied to thedevice. The method may also include monitoring an electrical signal fromthe device. The method may also include detecting an imminent creationof noise, or noise, caused by the suction; and reducing suction untilthe imminence of noise, or noise, subsides.

Yet another aspect of the invention may include a system for removingliquid from an ear canal. The system may include a suction probe, whichincludes at least one noise sensor. A pressure regulator may be coupledto the suction probe, the pressure regulator being configured to supplynegative pressure to the suction probe. A processor may also beelectrically coupled to the at least one noise sensor and pressureregulator, the processor being configured to detect, based on signalsfrom the at least one noise sensor, imminent creation of noise, ornoise, caused by the suction probe, the processor being furtherconfigured to modify pressure supplied by the pressure regulator basedon the signals.

Yet another aspect of the invention may include a device for silentlyremoving liquid from an ear canal. The device may include an elongatedcannula. Filtering material may be disposed within the cannula. Aportion of the filtering material may be extended out of an end of theelongated cannula.

Yet another aspect of the invention may include a method for silentlyremoving effusion from a middle ear. A tympanostomy tube including acentral lumen may be implanted into a tympanic membrane. A device havingan Archmides' screw may be inserted into the central lumen. TheArchmides' screw may be actuated to remove effusion lodged adjacent tothe tympanic membrane.

Yet another aspect of the invention may include a system for silentlyremoving effusion from a middle ear. The system may include atympanostomy tube including a central lumen. An elongated cannula may beconfigured to be slidably engaged with the lumen. An Archmides' screwmay be rotatably disposed within the cannula.

To better understand the nature and advantages of the invention,reference should be made to the following description and theaccompanying figures. It is to be understood, however, that the figuresand descriptions of exemplary embodiments are provided for the purposeof illustration only and are not intended as a definition of the limitsof the scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a direct view of an outer ear.

FIG. 1B shows a cross-sectional view of an outer, middle, and inner ear,and a Eustachian tube.

FIG. 2A shows a cross-sectional view of an earplug, according to oneembodiment of the invention.

FIG. 2B shows a perspective view of an earplug in use, according to oneembodiment of the invention.

FIG. 2C shows a flow chart of a method for removing effusion from amiddle ear, according to one embodiment of the invention.

FIG. 2D shows a frontal view of a device for sealing both ears of apatient, according to one embodiment of the invention.

FIG. 2E shows a frontal view of a device for sealing both ears of apatient in use, according to one embodiment of the invention.

FIG. 2F shows a perspective view of a device for sealing both ears of apatient, according to one embodiment of the invention.

FIGS. 2G and 2H show frontal and side views, respectively, of a devicefor sealing both ears of a patient in use, according to one embodimentof the invention.

FIG. 3A shows a side view of a device for silently removing liquid froman ear, according to one embodiment of the invention.

FIGS. 3B and 3C show frontal views of a device for silently removingliquid from an ear in use, according to one embodiment of the invention.

FIGS. 4A-4F show frontal views of liquid removal devices, according toembodiments of the invention.

FIGS. 4G-4I shows frontal views of liquid removal nozzles, according toembodiments of the invention.

FIG. 5A shows a side view of a device for silently removing liquid froman ear, according to one embodiment of the invention.

FIG. 5B shows a cross-sectional view of a device for silently removingliquid from an ear, according to one embodiment of the invention.

FIG. 5C shows a cross-sectional view of a device for silently removingliquid from an ear in use, according to one embodiment of the invention.

FIG. 6A shows a perspective view of a device for silently removingliquid from an ear, according to one embodiment of the invention.

FIG. 6B shows a cross-sectional view of a prior art device for removingliquid from an ear in use.

FIG. 6C shows a cross-sectional view of a device for removing liquidfrom an ear in use, according to one embodiment of the invention.

FIG. 7A shows a system diagram of a system for silently removing liquidfrom an ear, according to one embodiment of the invention.

FIG. 7B shows a flow chart for a method for silently removing liquidfrom an ear, according to one embodiment of the invention.

FIG. 8A shows a cross-sectional view of a device for silently removingliquid from an ear, according to one embodiment of the invention.

FIG. 8B shows a side view of the device of FIG. 8A coupled to a suctioncatheter, according to one embodiment of the invention.

FIG. 9A shows a cross-sectional view of a device for removing liquidfrom an ear, according to one embodiment of the invention.

FIG. 9B shows a cross-sectional view of the device of FIG. 9A in use,according to one embodiment of the invention.

FIG. 9C shows a side view of an alternative embodiment of the device ofFIG. 9A, according to one embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION Effusion Removal

FIG. 2A shows an earplug 200, according to one embodiment of theinvention. The earplug 200 includes a main lumen 202. One or moresealing members 204 extend from the main lumen 202. The sealing members204 are umbrella shaped, and configured to partially deform within anear canal to form a fluid tight seal. The sealing members 204 are shownto be integral from the main lumen 202, but may also be separatelyattached. The sealing members 204 are preferentially more flexible thanthe main lumen 202, as the main lumen 202 should remain at leastpartially open in use. A lumen seal 206 is placed within the main lumen202, which prevents fluid and pressure from exiting the lumen. The lumenseal 206 is shown configured as a duckbill valve, but may include otherconfigurations. For example, the lumen seal 206 may be an elastomericplug, or wall, with a compressed lumen, which may be expanded by adevice for inserting fluid, such as a syringe. The earplug 200 may beconstructed from various flexible materials, for example rubber orsilicone. Various configurations of the earplug 200 are possible, suchas shown in previously incorporated by reference U.S. Provisional PatentApplication No. U.S. 61/085,360.

FIG. 2B shows the earplug 200 in use, according to one embodiment of theinvention. As shown, a portion of the earplug 200 has been inserted intoan ear canal and another portion remains exposed adjacent to the outerear 208. The ear shown may have undergone a tympanocentesis procedure,shortly before insertion of the earplug. A sealing member 204 is alsoshown in a partially compressed state. Thus, the earplug 200 is fluidlysealed within the ear canal. A bulb device 210 or syringe may be coupledwith the earplug to supply fluidic pressure into the ear canal. Thefluid may be a liquid, such as iontophoresis fluid, saline, or water, ora gas, such as air. As the ear has undergone a tympanocentesisprocedure, the tympanic membrane has been punctured, and the ear canal118 is in fluidic communication with the middle ear 120. The patient maybe instructed to swallow, and thus induce the Eustachian tube to open.This action causes a pressure differential between the Eustachian tubeand the ear canal. Thus, fluid in the ear canal will pass through themiddle ear, and flush solid or semi-solid effusion inside the middle earinto the Eustachian tube. Alternatively, the bulb device 210 may be usedwithout instructing the patient to swallow. Creating a large enoughpressure differential between the ear canal and Eustachian tube willforce the Eustachian tube to open and move fluid through the middle ear.Care should be taken to avoid damage to the tympanic membrane. In analternative embodiment, a relief valve is included to preventover-pressurization of the ear canal. This procedure may also beperformed on both ears simultaneously, and with the patient sittingupright.

FIG. 2C shows a flow chart of a method 212 for removing effusion from amiddle ear, according to one embodiment of the invention. In operation214, a liquid is applied to the ear canal. The fluid may be liquid suchas iontophoresis fluid, saline, or water. The liquid is preferably atroom temperature, or higher, in order to prevent discomfort to thepatient. In an alternative embodiment, no liquid is provided foroperation 214, and the method begins at operation 216 using only gas asa fluid. At operation 216 an ear device is applied to the ear canal ofthe patient, to form a fluid tight seal between the ear canal and thesurrounding atmosphere. The ear device may, for example, be device 200as shown in FIGS. 2A and 2B. At operation 218 the ear device ispressurized with fluid, which may be a gas or liquid. The ear device maybe pressurized with an external device such as a syringe, catheter, orbulb device as shown in FIG. 2B. At operation 220 the Eustachian tube isinduced to open, which may occur from the patient swallowing or from thepressure created in operation 218. In operation 222 it is determinedwhether more fluid is required to complete the procedure. If not, thenthe procedure is complete and ends at 224. If more fluid is requiredthen the method 212 reverts to operation 218.

FIG. 2D shows a device 228 for sealing both ears of a patient, accordingto one embodiment of the invention. The device includes ear cups 230.Each ear cup 230 includes sealing members 232, which are configured tofit over and fluidly seal the outer ear of a patient. Each ear cup 230is provided with a fluid chamber 234, which fluidly communicates with anear canal. Each fluid chamber 234 in turn is in fluid communication witha port 236. The ports 236 include seals 238 for sealing the fluidchambers from the external atmosphere. The seals 238 may be constructedfrom a flexible material, such as silicone or rubber. The ports 236 maycouple to an external device which provides fluidic pressure, forexample a syringe, catheter, or bulb device as shown in FIG. 2B. In analternative embodiment each port 236 is connected to an integral airpump, which pressurizes each fluid chamber when manually or electricallyactivated. In another alternative embodiment, a relief valve is includedto prevent over-pressurization of the ear canal. A band 240 connectseach ear cup 230, and provides spring force for sealing each ear cup 230to a patient's head. FIG. 2E shows a front view of patient wearing thedevice 228.

FIG. 2F shows a device 242 for sealing both ears of a patient, accordingto one embodiment of the invention. The device includes ear cups 230,which may be constructed as described regarding FIG. 2D. The device 242includes a wrap-around headband 242. The headband 242 wraps around theentire head of a patient, and thus will not easily be disturbed during aprocedure. The headband may be constructed from an elastic material,such as rubber or silicone. FIGS. 2G and 211 show side and front views,respectively, of the device 242 in use on a patient.

Silent Liquid Removal:

FIG. 3A shows a device 300 for silently removing liquid from a patient'sear, according to one embodiment of the invention. Removing liquid inthe ear after a tympanocentesis procedure may be very disturbing to apatient, as a large amount of noise is created in the ear byconventional suction devices. The device 300 includes a syringe 302, anozzle 304, and an absorbent tip 306. The syringe 302 provides negativepressure for suctioning and retaining liquid. The nozzle 304 should beflexible to allow insertion into a tortuous ear canal without causingpatient discomfort. The nozzle 304 should also be flexible and longenough to reach the tympanic membrane without buckling or kinking. Thenozzle 304 may be constructed from a polymer, for example nylon,polycarbonate, polypropylene, polyethylene, silicone, or an annealed orsuper elastic alloy. The distal portion of the nozzle 304 may include anouter diameter ranging from 0.5-3.0 mm, which allows passage through aspeculum and visualization past the nozzle to ensure proper placementwithin the ear canal. The proximal portion of the nozzle 304 includes aluer fitting for coupling to the syringe 302. The absorbent tip 306 islocated within the distal portion of the nozzle 304. The absorbent tip306 may be constructed from absorbent materials such as porous fibers orfoam, which will wick liquids. Suitable materials include polyvinylacetate, rayon, and various blends of the two materials. The absorbenttip 306 may include pore sizes and interstitial spaces which attractliquid and retain particles. The absorbent tip 306 may extend 1-5 mmpast the distal portion of the nozzle.

FIG. 3B shows device 300 in use, according to one embodiment of theinvention. The device 300 is shown in use in an ear canal model 308which is partially filled with a liquid solution. The absorbent tip 306is initially placed in the ear canal and adjacent to the tympanicmembrane. Contact with the liquid solution causes an immediate wickingaction, which draws the liquid solution into the device 300. The wickingaction is completely silent, and thus will not disturb a patient. FIG.3C shows the syringe 302 has been slowly drawn back to suction theremaining liquid solution, accordingly, the liquid solution is silentlyand quickly removed. This method may be performed implementing aone-handed technique by the operator.

FIGS. 4A-4F show devices which may be used in lieu of the syringe 302with respect to device 300, according to different embodiments of theinvention. FIG. 4A shows a syringe with finger adapters which allows anergonomic one-handed suction motion. FIG. 4B shows a spring-loadedsyringe, which requires minimal effort to use. FIG. 4C shows a otologysuction device, which may connect to a standard suction line. FIG. 4Dshows a suction bulb, which is compressed before use. FIG. 4E shows asuction pipette, which is compressed before use. FIG. 4F shows abellows-type suction device, which is compressed before use.

FIGS. 4G-4I show devices which may be used in lieu of the nozzle 304with respect to device 300, according to different embodiments of theinvention. FIG. 4G shows a straight nozzle, which may offer bettervisibility in use. FIGS. 4H and 4I show shapeable nozzles of differentlengths, which may be shaped in the field by the operator for betteraccess and visibility.

FIGS. 5A and 5B show a device 500 for silently removing liquid from apatient's ear, according to one embodiment of the invention. The device500 includes an elongated cannula 502. The elongated cannula 502 may bepre-shaped to include a bend as shown, or in a straight configuration.The elongated cannula 502 may constructed from a malleable metal, andbent in the field by an operator for better access and visibility. Theelongated cannula 502 includes an outer diameter which is small enoughto reach the tympanic membrane, for example 1-3 mm. An elongated foammember 504 resides within the elongated cannula 502. The elongated foammember 504 includes a distal foam portion 506 and a proximal foamportion 508. The distal foam portion 506 extends past the elongatedcannula 502 by a small amount, e.g. 1-3 mm, in comparison to theproximal foam portion 508. A compressed region of foam 510 resideswithin the elongated cannula, and connects the distal and proximal foamportions. The foam may include pore sizes which can captureparticulates.

FIG. 5C shows the device 500 in use, according to one embodiment of theinvention. The distal foam portion 506 is shown placed in a liquidsolution. The distal foam portion 506 expands slightly upon immersion,but is largely restrained by the elongated cannula. Liquid is wickedsilently from the distal foam portion 506 to the proximal foam portion508. The proximal foam portion 508 has a larger volume than the distalfoam portion 506, and thus acts as a fluid depository. Accordingly,liquid is wicked from the distal foam portion 506 to the proximal foamportion 508 in a quick and silent manner. The device 500 requires noactuation other than placement in the ear. The proximal foam portion 508may be compressed to remove wicked fluid and reused during the procedureor in the other ear.

FIG. 6A shows a device 600 for silently removing liquid from a patient'sear, according to one embodiment of the invention. The device 600 isconfigured as a multi-lumen tube. The tube includes an outer diameterwhich is small enough to reach the tympanic membrane, for example 1-3mm. The lumen diameters may range from 0.05-0.5 mm. The device 600 maybe connected to a suction device, for example a suction line or syringe.The device may also be flexible or constructed from a malleablematerial. Noise may be created when air mixes with liquid in a lowpressure environment to cause cavitation and create a noisy “slurping”sound, as depicted in prior art device of FIG. 6B. Thus, the larger theinner diameter of the suction device, the more likely noise will beproduced, as any given cross-section of a large lumen may occupy bothair and water. Device 600 prevents unwanted cavitation by using severalsmaller diameter lumens, which ensures that only air or water occupies agiven cross-section of a lumen at a given time, as shown in FIG. 6C.Accordingly, the device 600 eliminates or greatly reduces cavitation toprovide a silent liquid evacuation procedure.

Closed-Loop Control System:

FIG. 7A shows a system 700 for silently removing liquid from a patient'sear, according to one embodiment of the invention. The system 700 isconfigured to gate the rate of suction, to a device, using a closed loopcontrol method. The system 700 includes a suction probe 702, whichincludes a probe tip 704, and at least one noise sensor 706. The suctionprobe 702 may be configured similarly to any of the devices disclosedherein, or may be a standard suction cannula. The sensor 706 may detectnoise (e.g. sound) and/or pressure and/or flow rate at or about theprobe tip 704, or any measureable artifact which is related to noiseproduction. For example, as suction noise is caused by turbulence in aliquid stream, which is detectable at the fluid/air interface at theprobe tip 704, detection of turbulence (e.g. presence, discontinuity,increase/decrease) may be used a detectable sensor artifact. Othermeasureable artifacts include heat/electrical conductivity (e.g. betweentwo points in a probe using the liquid as a conductive medium whereconductivity decreases with additional turbulence), evaporation, oxygencontent, temperature, or some other micro-environmental variable.Alternatively, several sensors may monitor conditions throughout theentire suction probe 702. The sensor 706 is electronically coupled to aprocessor 708. The processor 708 may be a portion of an embeddedcomputer. A trigger 710 sends user command signals to the processor 708,for example through a foot or hand switch. The suction probe 702receives suction from a regulator 714 which is further connected to asuction source 712. The regulator 714 is electronically coupled to theprocessor 708. The processor 708 controls the regulator 714 to vary therate and amount of negative pressure supplied to the suction probe 702.The sensor 706 may be configured to detect noise, or the imminentcreation of a predetermined noise level, and indicate the noisedetection to the processor. The processor 708 may modify, e.g. reduce oreliminate, negative pressure supplied to the suction probe 702 based onthe sensor 706 signal. In one example, the sensor is used to sense awaveform which increases in amplitude. Thus, when the waveform increasesto a predetermined level in velocity or amplitude, and/or accelerates ata predetermined rate, the processor 708 can reduce negative pressure tothe suction probe 702. Accordingly, the imminent increase/creation ofnoise to a predetermined level can be abated, as the processor preventsthe waveform from increasing. If no noise (e.g. no noise of asignificant discomfort level) is sensed by the sensor 706, then theprocessor 708 may increase negative pressure to the suction probe untila predetermined level is reached. A test cycle may also be implementedby the processor on start-up or shut-down by sending a test pulse ofnegative suction to create a suction-wave in the system 700 to check ifnoise is initially present, which may occur if the probe tip is onlypartially submerged in liquid, before full negative pressure is enactedby the regulator. Thus, negative pressure may not be applied at a fullrate and in a continuous mode if the probe is not fully immersed inliquid. Accordingly, the system 700 automatically prevents the creationof noise during a liquid evacuation procedure, and prevents discomfortto the patient.

The system 700 may include many of the components of a personalcomputer, such as a data bus, a memory, input and/or output devices(including a touch screen), and the like. The system 700 will ofteninclude both hardware and software, with the software typicallycomprising machine readable code or programming instructions forimplementing one, some, or all of the methods described herein. The codemay be embodied by a tangible media such as a memory, a magneticrecording media, an optical recording media, or the like. The system 700may have (or be coupled to) a recording media reader, or the code may betransmitted to the processor 708 by a network connection such as aninternet, an intranet, an Ethernet, a wireless network, or the like.Along with programming code, the system 700 may include stored data forimplementing the methods described herein, and may generate and/or storedata that records parameters reflecting the treatment of one or morepatients.

FIG. 7B shows a method 716 for silently removing liquid from a patient'sear, which may be used with system 700, according to one embodiment ofthe invention. A trigger occurs at input 716 to supply suction to thesuction probe 702. At operation 720 a processor 708 controls a regulator714 to supply suction to a suction probe 702. At operation 722 a sensor706 monitors noise at a probe tip 704 and sends a signal to theprocessor 708. At operation 724 it is determined whether the signalindicates noise, or imminent noise. If no noise, or imminent noise, isdetected, then the method 716 loops back to operation 720. If noise, orimminent noise, is detected, then at operation 726 the processor 708instructs the regulator 714 to reduce suction. At operation 728 it isagain determined whether the signal indicates noise, or imminent noise,after suction reduction. If no noise, or imminent, noise is detected,then the method 716 loops back to operation 720. If noise, or imminentnoise, is detected, then at operation 726 the processor 708 instructsthe regulator 714 to reduce suction again. Accordingly, the method 716automatically prevents the creation of noise during a liquid evacuationprocedure, and prevents discomfort to the patient.

FIG. 8A shows a device 800 for silently removing liquid from a patient'sear, according to one embodiment. The device 800 includes a cannula 802.In one embodiment the cannula 802 is a 0.075″ ID/0.083″ OD PTFE tubeapproximately 3.2 cm in length, with a 3/32″ thick polyolefin materialheat shrunk about the PTFE tube surface. The device 800 includes afilter material 804 within the cannula 802. In one embodiment the filtermaterial is 65 thread count cotton gauze strands which are 1.5-1.7 cmlong. In one embodiment, the filter material may be fibers of the cottongauze longitudinally arranged within the cannula 802. Alternatively, thefilter material may be constructed from porous foam strands. A portion806 of the filter material 804 extends from the distal end of thecannula 802. The portion 806 may be frayed to resemble a mop head. Thedevice 800 can be coupled to a commercially available 6 Fr suctioncatheter 808 as shown in FIG. 8B.

In use, the device 800 is applied to a liquid and/or light effusionwithin a patient's ear and suction is applied to the device 800, forexample, by using the catheter 808. The filtering material 804 acts as asound buffer by transferring the suction noise from the extreme distalend of the device to a more proximal location within cannula 802. Inother words, the noise of suction does not occur at the extreme distalend, near the patient's ear drum, but instead occurs more proximallywithin cannula 802. Accordingly, the patient is protected from excessivenoise due to the suction. The portion 806 extending from the cannula 802may also cushion against unintended contact with portions of the earcanal and/or be used to physically abrade lodged effusion.

FIGS. 9A and 9B show a system for silently removing liquid from apatient's ear, according to one embodiment of the invention. The device900 includes a cannula 902 and an Archimedes' screw 904 rotatablydisposed within the cannula 902. The Archimedes' screw 904 may becoupled to a drive motor (not shown) to rotate at a relatively slowrevolution, for example at 50-500 RPM, and at a constant torque. Thecannula 902 may include a flared tip 906. The Archimedes' screw 904 maybe configured to move in and out of the cannula. The cannula 902 may beconfigured to pass through a lumen 908 of a tympanostomy tube 910. Asuction source may be coupled to the proximal end of the device 900.

In use, the tympanostomy tube 910 is first implanted within a tympanicmembrane TM of an ear of a patient, as shown. Devices and methods forlocally anesthetizing the tympanic membrane for such a tube implantprocedure are disclosed in co-assigned patent applications U.S. Ser. No.11/962,063, U.S. Ser. No. 11/749,729, and U.S. 61/085,360, which wereincorporated by reference above. The device 900 can then be insertedinto the lumen 908 of the tympanostomy tube 910 and applied to a lodgedeffusion E. The Archimedes' screw 904 may rotate at a relatively slowRPM, and accordingly does not generate excessive noise, i.e. sputtering,to disturb the patient. Rotation of the Archimedes' screw 904 causes theeffusion E to engage Archimedes' screw 904 and travel out of the earcanal. The Archimedes' screw 904 may rotate at a constant torque toprevent jamming with particularly thick effusion. The Archimedes' screw904 may also be actuated in and out of the cannula to help disrupt thelodged effusion. Suction may be applied to the proximal portion of thedevice 900 to aid in effusion removal.

FIG. 9C shows an alternative embodiment of the device 900. A cannula 914includes a laterally exposed portion 914, which exposes the tip of theArchimedes' screw 904. The exposed portion 914 may allow the Archimedes'screw 904 to help initiate transport of the effusion.

It should be noted that the silent liquid removal systems and devicesshown and described herein may also be used to remove effusion. Forexample, the silent liquid systems and devices shown and describedherein may be inserted into an ear canal to remove effusion. The silentliquid systems and devices shown and described herein may also beinserted directly into the middle ear, following a myringotomy ortympanostomy, to remove lodged effusion. Accordingly, the systems anddevices for silent liquid removal described herein are not limited toremoving liquid drug solution, and may be used to remove any liquid andfluidic particulates within the ear.

As will be understood by those skilled in the art, the present inventionmay be embodied in other specific forms without departing from theessential characteristics thereof. Those skilled in the art willrecognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments of theinvention described herein. Such equivalents are intended to beencompassed by the following claims.

1. A method for clearing effusion from an ear, the method comprising:applying liquid to an ear canal, which is proximal to a perforatedtympanic membrane, which is proximal to a middle ear containingeffusion; applying an ear device to seal and pressurize the liquidinside the ear canal, the ear device regulating the amount of pressureinside the ear canal; and inducing a Eustachian tube, which is distal tothe middle ear, to open, which causes the fluid to displace the effusioninto the Eustachian tube. 2.-31. (canceled)